Study of Nicotine for the Prevention of PONV

Phase 2

Terminated

• Conditions: Postoperative Nausea and Vomiting
• Interventions: Drug: Nicotine

• Registration Number: NCT00553709
• Lead Sponsor: University Hospital, Geneva

Brief Summary

The purpose of this study is to determine whether nicotine is effective in the prevention of nausea and vomiting in non-smokers undergoing surgery

Detailed Description

Not available

Study Timeline

• Study Start: 2007-10
• Study First Submitted: 2007-11-02
• Study First Submitted QC: 2007-11-02
• Study First Posted: 2007-11-04
• Primary Completion: 2009-08
• Study Completion: 2009-08
• Status Verified: 2009-09
• Last Update Submitted: 2009-09-28
• Last Update Posted: 2009-09-29

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Adults (18-80 years)
• ASA I-II, non-smokers (or ex-smokers who have not been smoking for more than 2 years)
• Undergoing elective surgery (ENT, abdominal, urological, gynaecological); and
• Consenting to take part in the study will be included.

Exclusion Criteria

• Smokers (cigarette, pipe, cigar)
• Patients undergoing nicotine replacement therapy
• Prolonged postoperative intubation
• Postoperative nasogastric tube

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo patch	Nicotine	Placebo patch 10 cm2
Nicotine patch	Nicotine	Nicotinell® Patch 10 cm2, containing 17.5 mg of nicotine, with an average delivery rate of 7 mg of nicotine per 24 hours (= TTS 10)

Primary Outcome Measures

Name	Time	Method
Prevention of PONV	48 hours postoperatively

Secondary Outcome Measures

Name	Time	Method
Adverse effects that may be related to the nicotine patch, for instance, local skin reaction.	48 hours postoperatively

Trial Locations

Locations (1)

Division of Anesthesiology, Geneva University Hospitals; 🇨🇭 Geneva, Switzerland